Device Classification Name |
Full-Montage Standard Electroencephalograph
|
510(k) Number |
K905435 |
Device Name |
UNIQUANT |
Applicant |
NEUROCONCEPTS, INC. |
6510 SCHROEDER RD. |
MADISON,
WI
53711
|
|
Applicant Contact |
DENNIS ROSCOE |
Correspondent |
NEUROCONCEPTS, INC. |
6510 SCHROEDER RD. |
MADISON,
WI
53711
|
|
Correspondent Contact |
DENNIS ROSCOE |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 12/04/1990 |
Decision Date | 07/22/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|